The geko™ device receives FDA 510(k) for edema reduction supporting entry in the USA.
Sky Medical Technology Ltd, parent company of Firstkind Ltd, a UK based innovator and manufacturer of medical devices, announced today it has received U.S. Food and Drug Administration (FDA) clearance to market the geko™ device for oedema reduction to address all pre and post-operative clinical applications in the USA.
"We are delighted to receive this 510k clearance for edema reduction, said Sky CEO Bernard Ross. The clearance reflects our strengths in providing high-impact therapies that address clinical unmet needs. Expansion into oedema reduction in the USA, to treat all pre and post-operative clinical applications, is a major strategic development for the company and builds on our prior 510k clearance for increasing blood flow and post-surgical VTE prevention; and our ambition to provide proven enhanced recovery across the US and internationally. Through our central strategy in partnering with healthcare professionals to solve challenging medial problems, we identify and translate clinical needs into cutting-edge products and evidence-based protocols to establish new standards of care that simplify treatments for clinicians and improve patient outcomes".
The geko™ is a battery powered, disposable neuromuscular electrostimulation device. The size of a wrist-watch and worn at the knee, the geko™ gently stimulated the common peroneal nerve activating the calf and foot muscle pumps resulting in increased blood flow and the reduction of pre and post-operative edema. The increase in blood flow is equal to 60% of walking without a patient having to move or exert energy.
See the geko™ device at AAOS (American Academy of Orthopaedic Surgeons) in New Orleans, March 7-9th in booth #6934, in the first-time exhibitors’ area.
About Sky Medical Technology
Sky Medical Technology is a UK based medical devices company that has developed a ground-breaking neuromuscular electrostimulation platform, OnPulse™. The company develops a range of products tailored to different medical applications, selling both direct, through partnerships or distributors in each clinical area. Clinical areas of interest include DVT (blood clot) prevention, reduction of swelling, wound healing and elite-sport recovery. The goal in each clinical area is to improve clinical outcomes and patient care whilst saving health system resources.
Anthony Kjenstad (310) 628-5163